Cleared Traditional

K953446 - AESCULAP BIPOLAR CORDS

K953446 is the FDA 510(k) clearance for AESCULAP BIPOLAR CORDS by Aesculap, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K953446 · Aesculap, Inc. · General & Plastic Surgery device
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Sep 1995
Decision
74d
Days
Class 2
Risk

K953446 is an FDA 510(k) clearance for the AESCULAP BIPOLAR CORDS. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on September 29, 1995 after a review of 74 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Aesculap, Inc. devices

Submission Details

510(k) Number K953446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1995
Decision Date September 29, 1995
Days to Decision 74 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 115d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1118
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K953446.
CONMED ELECTROSURGICAL GROUNDING PAD
K954633 · Conmedcorp · Oct 1995
BIPOLAR FORCEPS
K953479 · Megadyne Medical Products, Inc. · Oct 1995
ERBOTOM ICC BIPOLAR
K953159 · Erbe USA, Inc. · Oct 1995
UNIVERSAL PLUS ES S/I INSTRUMENT
K954056 · Conmedcorp · Sep 1995
BIPOLAR GENERATOR MODEL 2352
K945914 · Richard Wolf Medical Instruments Corp. · Sep 1995
TAKE-APART SCISSORS
K954122 · KARL STORZ Endoscopy-America, Inc. · Sep 1995